Steps Ahead: Optimising Physical Activity and Health in Adults With Cystic Fibrosis

NCT03672058 | Completed

• 1 other identifier: CF UHL UL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Physical activity is widely documented as one of the cornerstones of Cystic Fibrosis (CF) management as it is directly linked to mortality and quality of life. Levels of physical inactivity and sedentary behaviour have been poorly investigated among the CF population in Ireland. The measurement of these behaviours is important in order to monitor prevalence amongst people with CF (PWCF) and determine methods by which health care providers can assist with maintaining and enhancing physical activity. The use of physical activity monitoring can provide health care providers with insightful real world analysis of physical activity and exercise behaviours. Over the last decade there has been many advancements in technology and fitness tracking with positive results being demonstrated in the healthy population and in chronic diseases such as Diabetes Mellitus II, post surgery and Multiple Sclerosis. Limited research has been conducted among PWCF to date. The aim of this research project is to examine physical activity levels amongst PWCF and determine the effect of a 12 week randomised parallel intervention on a number of health outcomes. Participants will be provided with an accelerometer to assess physical activity and sedentary behaviour at baseline. The participants will then undergo further baseline testing to determine exercise capacity, body composition, quality of life, breathlessness, sleep quality and wellbeing. Baseline short and long term goals will be established together with the participant and physiotherapist. Participants will then be randomly allocated to either the intervention or the comparator. A researcher independent of the recruitment process (MC) will complete the first random allocation using a sealed opaque envelope. Following this a minimisation randomisation procedure will be completed based on lung function, where FEV1 of \<70% predicted lung function will be classified as having mild lung disease. While those with an FEV1 of 30-50% predicted lung function will be classified as having moderate lung disease, with \<30% indicating severe lung disease. Allocation will be revealed after recruitment and baseline assessments have occurred. Both groups will receive a fitness tracker which will be linked to an online monitoring system (Fitabase) for 24 weeks. The intervention group will receive personalised feedback via a text message every week on their physical activity levels as measured by their fitness tracker and progress on attainment of their goals established at the start of the study. Feedback will be provided from their CF physiotherapists. The comparator group will not receive any feedback on their Fitbit data. After 12 weeks both groups will be re-assessed. Thereafter, both groups will continue with the Fitbits alone for 12 weeks. Finally outcome measures including lung function, physical activity levels, aerobic capacity, quality of life, sleep quality, muscle mass and well-being will be re-assessed again at 24 weeks. Following the intervention semi structured interviews will be conducted to qualitatively establish satisfaction with the interventions and provide insight into barriers and enablers to achieving goals and physical activity levels.The results of this study may provide valuable insights into potential interventions to optimise the health and well-being of PWCF.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis, CF

Outcome Measures

Primary Outcomes (3)

• Change in forced expiratory volume in 1 second (FEV1) (%predicted)

  Spirometry

  Baseline to 3 months and Baseline to 6 months

• Change in peak oxygen uptake (% predicted)

  Cardiopulmonary Exercise Testing

  Baseline to 3 months and Baseline to 6 months

• Change in number of steps per day

  Fitbit/Activpal

  Baseline to 3 months and Baseline to 6 months

Secondary Outcomes (12)

• Change in maximal aerobic power (%predicted)

  Baseline to 3 months and Baseline to 6 months

• Change in forced expiratory volume (FVC) (%predicted)

  Baseline to 3 months and Baseline to 6 months

• Change in grip strength

  Baseline to 3 months and Baseline to 6 months

• Change in body mass index (kg/m2)

  Baseline to 3 months and Baseline to 6 months

• Change in muscle mass (kg)

  Baseline to 3 months and Baseline to 6 months

Other Outcomes (2)

• Time to exacerbation

  Baseline to 3 months and Baseline to 6 months

• Semi Structured Interviews

  At 6 months

Study Arms (2)

Fitbit plus personalised text messaging & Goal Setting

EXPERIMENTAL

Other: Fitness tracker with goal setting and text message feedback

Fitbit Only

ACTIVE COMPARATOR

Other: Fitness Tracker only

Interventions

Fitness tracker with goal setting and text message feedback OTHER

Participants provided with a Fitbit and this will also be linked to Fitabase. The physiotherapist will discuss the participants' baseline physical activity levels and individual patient centred short and long-term goals will be set with each participant. Every week participants will be contacted via text message by their CF physiotherapist. The physiotherapist will review their online data and will provide feedback and encouragement on their progress. Goals will be reviewed for each participant.

Fitbit plus personalised text messaging & Goal Setting

Fitness Tracker only OTHER

Participants will be provided with the Fitbit and educated on how to use it. This will be linked to "Fitabase", an online monitoring system for data collection purposes, with the consent of the participants. However no goal setting will be completed and no feedback will be provided to the participants on their physical activity levels

Fitbit Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically stable CF patients
• Age \> 18 years
• Confirmed diagnosis of CF
• Access to a smartphone/tablet to access and upload to Fitbit Application.
• Capacity and willingness to give explicit informed consent

You may not qualify if:

• FEV1 \< 25%.
• Patients on the waiting list for lung transplantation and those who have undergone lung transplantation.
• Patients with an exacerbation in the four weeks prior to the study. For the purpose of this study pulmonary exacerbation will be defined as acute or subacute worsening of respiratory symptoms which warrant change in treatment (i.e., new oral or intravenous antibiotics). Patients can undergo testing once they are finished their antibiotics and deemed clinically stable.
• Patients dependent on supplemental oxygen for exercise.
• Pregnancy
• Participation in another clinical trial up to 4 weeks prior to the first baseline visit

Sponsors & Collaborators

• University of Limerick: lead

Study Sites (1)

University Hospital Limerick

Limerick, Ireland

Location

Related Publications (1)

• Curran M, Tierney AC, Collins L, Kennedy L, McDonnell C, Jurascheck AJ, Sheikhi A, Walsh C, Button B, Galvin R, Casserly B, Cahalan R. Steps Ahead: optimising physical activity in adults with cystic fibrosis: Study Protocol for a pilot randomised trial using wearable technology, goal setting and text message feedback. HRB Open Res. 2020 Nov 16;3:21. doi: 10.12688/hrbopenres.13025.3. eCollection 2020.

  PMID: 33283151 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies

Study Officials

• Roisin Cahalan, PhD

  University of Limerick

  PRINCIPAL INVESTIGATOR

• Audrey Tierney, PhD

  University of Limerick

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2018
• First Posted: September 14, 2018
• Study Start: October 1, 2018
• Primary Completion: June 28, 2020
• Study Completion: June 28, 2020
• Last Updated: January 30, 2025

Record last verified: 2025-01

Locations

IE (1)